Real world outcomes using 20 mm balloon expandable SAPIEN 3/ultra valves compared to larger valves (23, 26, and 29 mm)–a propensity matched analysis

Abstract

Objective/Background: Small balloon expandable valves have higher echocardiographic transvalvular gradients and rates of prosthesis-patient mismatch (PPM) compared to larger valves. However, the impact of these echocardiographic findings on clinical outcomes is unknown. We sought to determine the clinical outcomes of 20 mm SAPIEN 3 (S3 BEV) compared to larger S3 BEV in relation to echocardiographic hemodynamics.Methods: Using the STS/ACC transcatheter valve registry, we performed a propensity-matched comparison of patients undergoing treatment of native aortic valve stenosis using transfemoral, balloon-expandable implantation of 20 mm and ≥ 23 mm S3 BEVs. Baseline and procedure characteristics, echocardiographic variables and survival were analyzed. Multivariable logistic regression was used to identify predictors of 1-year mortality.Results: After propensity matching of the 20 mm and ≥ 23 mm SAPIEN 3 valves, 3,931 pairs with comparable baseline characteristics were identified. Small valves were associated with significantly higher echocardiographic gradients at discharge (15.7 ± 7.1 mmHg vs. 11.7 ± 5.5 mmHg, p < 0.0001) and severe PPM rates (21.5% vs. 9.7%, p < 0.0001). There was no significant difference in 1-year all-cause mortality (20 mm: 13.0% vs. ≥23 mm: 12.7%, p = 0.72) or other major adverse event rates and outcomes between the two cohorts. Based on a multivariable analysis, elevated discharge mean gradient (>20 mmHg), severe PPM and the use of 20 mm versus ≥23 mm were not independent predictors of 1-year mortality.Conclusion: SAPIEN 3 20 mm valves were associated with higher echocardiographic gradients, and severe PPM rates compared to larger valves but these factors were not associated with significant differences in 1-year all-cause mortality or rehospitalization. K E Y W O R D S structural heart disease, transcatheter aortic valve replacement, TVT registry Statistical analyses were performed by Edwards Lifesciences. The views or opinions presented here do not represent those of the American College of Cardiology, the Society of Thoracic Surgeons, or the STS/ACC TVT Registry.

Prosthesis‐patient mismatch after transcatheter implantation of contemporary balloon‐expandable and self‐expandable valves in small aortic annuli

“…In our study, significant impact of severe PPM on mortality was observed in IAV and BEV, but not in SEV cohort. These findings collide with previous results from PARTNER 3 trial, which seemed to suggest no prognostic relevance of PPM after Sapien 3 implantation, 11 recently confirmed in a high‐numerosity propensity‐matched cohort of patients treated with BEV 21 . On the other hand, severe PPM did predict mortality in the CoreValve US High‐Risk trial, 9 even though this was not confirmed in a recent analysis of 47,620 patients from the Transcatheter Valve Therapy registry 10 .…”

“…These findings collide with previous results from PARTNER 3 trial, which seemed to suggest no prognostic relevance of PPM after Sapien 3 implantation, 11 recently confirmed in a high-numerosity propensitymatched cohort of patients treated with BEV. 21 On the other hand, severe PPM did predict mortality in the CoreValve US High-Risk trial, 9 even though this was not confirmed in a recent analysis of 47,620 patients from the Transcatheter Valve Therapy registry. 10 Reasons behind the described selective prognostic impact of severe PPM might include derivation of echocardiographic mean gradients from transaortic velocity, and are being addressed.…”

Unfolding Mystery of Aortic Transcatheter Valve Doppler Gradient and Clinical Outcomes

“…Twenty-millimeter-diameter balloon-expandable valves used in patients with small annuli and aortas are known to be associated with higher discharge Doppler MG >20 mm Hg, yet are associated with similar survival compared with larger valve sizes. 4 Furthermore, correlation between Doppler and invasive pressure measurement may vary depending on the type of transcatheter valve. Balloon-expandable valves are observed to have higher MG by Doppler, yet lower invasive MG compared with self-expanding valves.…”